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Long-Term Follow-up Study of Patients Who Received PB127 Ultrasound Imaging Agent

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ClinicalTrials.gov Identifier: NCT00584714
Recruitment Status : Terminated (Discontinued PB127 development program for business reasons)
First Posted : January 2, 2008
Last Update Posted : July 3, 2008
Sponsor:
Information provided by:
Point Biomedical

Brief Summary:
The purpose of this study is to collect longer term follow-up information concerning health and survival on selected patients who received PB127 for injectable suspension in the pivotal trial (127-014).

Condition or disease
Coronary Artery Disease

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Long-Term Follow-Up of Selected Patients Enrolled in Phase 3 Clinical Trial 127-014 Using PB127 Ultrasound Imaging Agent
Study Start Date : October 2007
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008



Primary Outcome Measures :
  1. To collect longer-term follow-up clinical information on selected patients enrolled in Protocol 127-014 [ Time Frame: 1 year ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with low/very low pre-test probability of coronary artery disease enrolled in Protocol 127-014 who did not have or were not schedule to undergo coronary angiography at the time of enrollment and did not have a clinical outcome during the initial 6 month follow-up period.
Criteria

Inclusion Criteria:

Patients enrolled in Protocol 127-014 who

  1. Were enrolled in Stratum 1
  2. Did not undergo angiography during study evaluation
  3. Did not have a clinical oucome during the initial 6 month follow-up period as described in Protocol 127-014.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584714


  Show 39 Study Locations
Sponsors and Collaborators
Point Biomedical
Investigators
Study Director: Alexander Ehlgen, MD, PhD POINT Biomedical Corp.

Responsible Party: Tom Ottoboni PhD/Chief Operating Officer, POINT Biomedical Corp.
ClinicalTrials.gov Identifier: NCT00584714     History of Changes
Other Study ID Numbers: 127-014-A
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: July 3, 2008
Last Verified: July 2008

Keywords provided by Point Biomedical:
ultrasound
perfusion
SPECT
coronary artery disease
chest pain
low probability
angiography
clinical outcomes

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases